The present application generally concerns the field of collecting and analyzing body fluid samples.
Portable blood testing equipment, such as for blood glucose, cholesterol, etc., has gained in popularity in home diagnostic, medical, and/or veterinary environments due to their improved convenience. One significant drawback in portable testing is the pain associated with lancing the skin to collect a fluid sample. Pain can be reduced by penetrating the skin at shallower depths, but less blood and/or interstitial fluid is typically produced. For the home diagnostic market, consumers want the test to be painless, convenient, and short so as to minimally interfere with day-to-day activities. In the present market place, non-integrated testing products dominate in which separate lancets and test strips are used to produce and analyze the fluid sample. However, to ensure a successful test, these non-integrated approaches usually require relatively large sample volumes, and hence, they need painfully deep incisions. Due to the number of separate steps involved, these non-integrated systems are not very convenient and require a significant amount of time to perform a successful test.
Integrated disposables have been proposed that incorporate some type of lancet or needle with a testing means like a test strip such that lancing, fluid collection, and sample analysis steps occur almost instantaneously within a single unit. While integrated disposables are more convenient and can collect smaller blood samples at shallower penetration depths, integrated disposables have yet to achieve commercial success due to a number of factors. Commercially successful integrated disposables have not been implemented due to several factors. One major factor is the low success test rate of the current batch of integrated disposables. Current testing methodologies use separate lancets and test strips. In a traditional test, the lancet is used to pierce the skin, and when a drop of blood forms on the skin, the separate test strip is used to collect and analyze the sample. With these current methodologies, if one of the steps proves problematic, other steps or options can be taken such that a useful test can be obtained without the need for abandoning the entire procedure. In other words, with the traditional non-integrated approach, users can intervene in the collection process so as to ensure that a successful test can be performed. For example, the user can re-lance the skin and/or pinch the skin around the incision to express additional fluid without wasting a test strip. In contrast, the various sources of fluid collection failures in integrated disposables are cumulative in nature such that a failed test leads to the complete loss of the integrated disposable. Typically with integrated disposables a user gets one shot so all of the various steps of piercing the skin, drawing the fluid, and analyzing the fluid must be performed flawlessly. If one step is unsuccessful, the entire test fails, and the integrated disposable is usually wasted and replaced with a new one, thereby eliminating some of the advantages of integrated systems. As should be recognized, these test failures can make the operational costs for the system quite expensive. Further, this need for multiple attempts to conduct a successful test can frustrate the user.
Thus, there is a need for improvement in this field.